[Federal Register Volume 76, Number 38 (Friday, February 25, 2011)]
[Notices]
[Pages 10600-10602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4295]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1347-N]
Medicare Program; Public Meeting in Calendar Year 2011 for New
Clinical Laboratory Tests Payment Determinations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces a public meeting to receive comments and
recommendations (including accompanying data on which recommendations
are based) from the public on the appropriate basis for establishing
payment amounts for a specified list of new Clinical Procedural
Terminology (CPT) codes for clinical laboratory tests in calendar year
(CY) 2012. The meeting provides a forum for interested parties to make
presentations and submit written comments on the new codes that will be
included in Medicare's Clinical Laboratory Fee Schedule for CY 2012,
which will be effective on January 1, 2012. The development of the
codes for clinical laboratory tests is largely performed by the CPT
Editorial Panel and will not be further discussed at the meeting.
DATES: Meeting Date: The public meeting is scheduled for Monday, July
18, 2011 from 9 a.m. to 2 p.m., Eastern Standard Time (E.S.T.).
Deadline for Registration of Presenters: All presenters for the
public meeting must register by July 11, 2011.
Deadline for Submitting Requests for Special Accommodations:
Requests for special accommodations must be received no later than 5
p.m., E.S.T. on July 11, 2011.
Deadline for Submission of Written Comments: Interested parties may
submit written comments on the proposed payment determinations by
September 23, 2011, to the address specified in the ADDRESSES section
of this notice. We note that comments submitted should pertain to the
payment basis for a specified list of new Clinical Procedural
Terminology (CPT) codes.
ADDRESSES: The public meeting will be held in the main auditorium of
the central building of the Centers for Medicare & Medicaid Services
(CMS), 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
FOR FURTHER INFORMATION CONTACT: Glenn McGuirk, (410) 786-5723.
SUPPLEMENTARY INFORMATION:
I. Background
Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554)
requires the Secretary to establish procedures for coding and payment
determinations for new clinical diagnostic laboratory tests under Part
B of title XVIII of the Social Security Act (the Act) that permit
public consultation in a manner consistent with the procedures
established for implementing coding modifications for International
Classification of Diseases (ICD-9-CM). The procedures and public
meeting announced in this notice for new clinical laboratory tests are
in accordance with the procedures published on November 23, 2001 in the
Federal Register (66 FR 58743) to implement section 531(b) of BIPA.
Section 942(b) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
[[Page 10601]]
L. 108-173) added section 1833(h)(8) of the Act. Section 1833(h)(8)(A)
of the Act requires the Secretary to establish by regulation procedure
for determining the basis for, and amount of, payment for any clinical
diagnostic laboratory tests with respect to which a new or
substantially revised Healthcare Common Procedures Coding System
(HCPCS) code is assigned on or after January 1, 2005 (hereinafter
referred to as, ``new test'' or ``new clinical laboratory test'').
Section 1833(h)(8)(B) of the Act sets forth the process for determining
the basis for, and the amount of, payment for new tests. Pertinent to
this notice, section 1833(h)(8)(B)(i) and section 1833(h)(8)(B)(ii) of
the Act requires the Secretary to make available to the public a list
that includes new tests for which establishment of a payment amount is
being considered for a year and, on the same day that the list is made
available, to publish in the Federal Register a notice of a meeting to
receive comments and recommendations (including accompanying data on
which recommendations are based) from the public on the appropriate
basis for establishing payment amounts for new tests. Section
1833(h)(8)(B)(iii) of the Act requires that we convene a public meeting
not less than 30 days after publication of the notice in the Federal
Register. These requirements are codified at 42 CFR part 414, subpart
G.
A newly created Current Procedural Terminology (CPT) code can
represent either a refinement or modification of existing test methods,
or a substantially new test method. The preliminary list of newly
created CPT codes for calendar year (CY) 2012 will be published on our
Web site as soon as possible at http://www.cms.hhs.gov/ClinicalLabFeeSched.
Two methods are used to establish payment amounts for new tests
included in the CY 2012 Clinical Laboratory Fee Schedule. The first
method called ``cross-walking'' is used when a new test is determined
to be comparable to an existing test, multiple existing test codes, or
a portion of an existing test code. The new test code is then assigned
to the related existing local fee schedule amounts and the related
existing national limitation amount. Payment for the new test is made
at the lesser of the local fee schedule amount or the national
limitation amount. We refer readers to Sec. 414.508(a).
The second method called ``gap-filling'' is used when no comparable
existing test is available. When using this method, instructions are
provided to each Medicare carrier or Part A and Part B Medicare
Administrative Contractor (MAC) to determine a payment amount for its
geographic area(s) for use in the first year. These determinations are
based on the following sources of information, if available: Charges
for the test and routine discounts to charges; resources required to
perform the test; payment amounts determined by other payers; and
charges, payment amounts, and resources required for other tests that
may be comparable or otherwise relevant. The carrier-specific amounts
are used to establish a national limitation amount for the following
years. We refer readers to Sec. 414.508(b). For each new clinical
laboratory test code, a determination must be made to either cross-walk
or gap-fill.
II. Format
This meeting to receive comments and recommendations (including
accompanying data on which recommendations are based) on the
appropriate payment basis for the specified list of new CPT codes is
open to the public. The on-site check-in for visitors will be held from
8:30 a.m., E.S.T. to 9 a.m., E.S.T., followed by opening remarks.
Registered persons from the public may discuss and recommend payment
determinations for specific new test codes for the CY 2012 Clinical
Laboratory Fee Schedule.
Presentations must be brief and accompanied by three written
copies. CMS recommends that presenters make copies available for
approximately 50 meeting participants, since CMS will not be providing
additional copies. Presentations must also be electronically submitted
to CMS on or before July 1, 2011. Presentations should be sent via e-
mail to Glenn McGuirk, at [email protected]. Once the
presentations are collected, CMS will post them on the Clinical
Laboratory Web site at http://www.cms.hhs.gov/ClinicalLabFeeSched.
Presenters should address the following items:
New test code(s) and descriptor.
Test purpose and method.
Costs.
Charges.
Make a recommendation with rationale for one of two
methods (cross-walking or gap-fill) for determining payment for new
tests.
Additionally, the presenters should provide the data on which their
recommendations are based. Presentations that do not address the above
5 items may be considered incomplete and may not be considered by CMS
when making a payment determination. CMS may request missing
information following the meeting in order to prevent a recommendation
from being considered incomplete.
A summary of the proposed new test codes and the payment
recommendations that are presented during the public meeting will be
posted on the CMS Web site by early September 2011 and can be accessed
at http://www.cms.hhs.gov/ClinicalLabFeeSched. The summary on the CMS
website will include a list of all comments received by August 8, 2011
(15 business days after the meeting). The summary will also include our
proposed determinations with respect to the appropriate basis for
establishing a payment amount for each code, an explanation of the
reasons for each determination, the data on which the determinations
are based, and a request for public written comments on the proposed
determinations. Interested parties may submit written comments on the
proposed payment determinations by September 23, 2011, to the address
specified in the ADDRESSES section of this notice. Final payment
determinations will be posted on our website in October 2011. Each
determination will include a rationale, data on which the determination
is based, and responses to comments and suggestions received from the
public.
After the final payment determinations have been posted on our Web
site, the public may request reconsideration of the basis for and
amount of payment for a new test as set forth in Sec. 414.509. We also
refer readers to the November 27, 2007 final rule (72 FR 66275 through
66280).
III. Registration Instructions
The Division of Ambulatory Services in CMS is coordinating the
public meeting registration. Beginning June 20, 2011, registration may
be completed on-line at the following Web address: http://www.cms.hhs.gov/ClinicalLabFeeSched. The following information must be
submitted when registering:
Name.
Company name.
Address.
Telephone number(s).
E-mail address(es).
When registering, individuals who want to make a presentation must
also specify on which new clinical laboratory test code(s) they will be
presenting comments. A confirmation will be sent upon receipt of the
registration. Individuals must register by the date specified in the
DATES section of this notice.
[[Page 10602]]
IV. Security, Building, and Parking Guidelines
The meeting will be held in a Federal government building;
therefore, Federal security measures are applicable. In planning your
arrival time, we recommend allowing additional time to clear security.
It is suggested that you arrive at the CMS facility between 8:15 a.m
and 8:30 a.m., E.S.T. so that you will be able to arrive promptly at
the meeting by 9 a.m., E.S.T. Individuals who are not registered in
advance will not be permitted to enter the building and will be unable
to attend the meeting. The public may not enter the building earlier
than 8:15 a.m., E.S.T. (45 minutes before the convening of the
meeting).
Security measures include the following:
Presentation of government-issued photographic
identification to the Federal Protective Service or Guard Service
personnel. Persons without proper identification may be denied access
to the building.
Interior and exterior inspection of vehicles (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and instructions will be issued after the vehicle
inspection.
Passing through a metal detector and inspection of items
brought into the building.
We note that all items brought to CMS, whether personal or for the
purpose of demonstration or to support a demonstration, are subject to
inspection. We cannot assume responsibility for coordinating the
receipt, transfer, transport, storage, set-up, safety, or timely
arrival of any personal belongings or items used for demonstration or
to support a demonstration.
V. Special Accommodations
Individuals attending the meeting who are hearing or visually
impaired and have special requirements, or a condition that requires
special assistance, should provide the information upon registering for
the meeting. The deadline for such registrations is listed in the DATES
section of this notice.
VI. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: February 18, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-4295 Filed 2-24-11; 8:45 am]
BILLING CODE 4120-01-P